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RSS FeedPosted by Michael Wonder on 11 Nov 2021
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted by Michael Wonder on 09 Nov 2021
Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...
Posted by Michael Wonder on 08 Nov 2021
EMA publishes agenda for 8-11 November CHMP meeting
8 November 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 08 Nov 2021
SMC - November 2021 decisions
8 November 2021 - The Scottish Medicines Consortium which advises on newly licensed medicines for use by NHSScotland has published ...
Posted by Michael Wonder on 08 Nov 2021
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
8 November 2021 - EMA starts review to support possible national decisions on early use. ...
Posted by Michael Wonder on 03 Nov 2021
Trastuzumab deruxtecan type II variation application validated by EMA for the treatment of HER2 positive advanced gastric cancer
3 November 2021 - Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials. ...
Posted by Michael Wonder on 02 Nov 2021
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
Posted by Michael Wonder on 02 Nov 2021
Otsuka submits initial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease
29 October 2021 - Otsuka announces that Otsuka Pharmaceutical Netherlands has submitted an initial marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 29 Oct 2021
Incyte announces the validation of the European marketing authorisation application for ruxolitinib cream in vitiligo
28 October 2021 - The marketing authorisation application seeks approval of ruxolitinib cream for the treatment of adolescent and adult patients ...
Posted by Michael Wonder on 29 Oct 2021
Reata Pharmaceuticals submits marketing authorisation application to the EMA for bardoxolone methyl in chronic kidney disease caused by Alport syndrome
28 October 2021 - Reata Pharmaceuticals today announced its submission of a marketing authorisation application for bardoxolone methyl to the ...
Posted by Michael Wonder on 28 Oct 2021
EMA nod for excessive daytime sleepiness med Ozawade
28 October 2021 - The EMA has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness associated with ...
Posted by Michael Wonder on 28 Oct 2021
Repurposing of authorised medicines: pilot to support not for profit organisations and academia
28 October 2021 - EMA and the Heads of Medicines Agencies are launching a pilot project to support the repurposing ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...